Course Description

Course title:

GHTF/IMDRF – Supporting Documents

Course ID: N172

Course Description:

This course provides an in depth review of the documents prepared by the GHTF/IMDRF which support the pre- and post-market regulatory models for medical devices. They also provide guidance for both manufacturers and regulatory agencies on quality management systems requirements, auditing and clinical evidence.

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Learning Objectives:

Upon completion of this course, trainees will have gained knowledge of the final pieces which comprise the GHTF/IMDRF model for regulating medical devices and support the major pillars of the international regulatory framework.

Who Should Enroll:

Regulatory affairs, quality assurance and clinical professionals in industry or regulators with an interest in the global market.

Prerequisite Knowledge/Requirements:

IDN 169 - Introduction to the Global Harmonization Task Force.

IDN 170 - GHTF/IMDRF – The Premarket Model.

IDN 171 - GHTF/IMDRF – The Post-market Model.

Knowledge of the European system for device regulation is also useful; however, this course can be considered as an introduction to it.

About WMDO

WMDO provides you with the extensive knowledge and unrivaled experience of the medical device industry's leading experts and authorities to deliver the latest and most effective online medical device training available in the world.